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Study on the Effectiveness of Chaste Tree Extract (Vitex agnus-castus BNO 1095) for Women with Menstrual Cramps (Primary Dysmenorrhea)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for primary dysmenorrhea, which is a condition characterized by cramping pain in the lower abdomen that occurs just before or during menstruation. The treatment being tested is a herbal medicine called Vitex agnus-castus BNO 1095, which is derived from the chaste tree fruit. The study aims to determine if this treatment can help reduce the symptoms of primary dysmenorrhea in women.

Participants in the study will be randomly assigned to receive either the Vitex agnus-castus BNO 1095 treatment or a placebo. The study will last for three menstrual cycles, during which the effectiveness of the treatment will be assessed. The goal is to see if there is an improvement in the cramping pain experienced by participants who take the herbal medicine compared to those who receive the placebo.

The study will monitor the participants' symptoms over the course of the treatment period to evaluate any changes in their condition. The main focus is to observe a reduction in the peak pelvic pain score and to ensure that there is no increase in the use of standard pain relief medication during the treatment. This trial is designed to provide valuable information on whether Vitex agnus-castus BNO 1095 can be an effective option for managing primary dysmenorrhea.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is informed about the nature, scope, and relevance of the clinical trial. The patient voluntarily agrees to participate and signs the informed consent form.

  2. Step 2

    Treatment phase

    The patient receives either Vitex agnus-castus BNO 1095 (20 mg) or a placebo. The treatment is administered orally.

    The treatment duration is over three menstrual cycles, specifically during the cramping windows of Cycles 3 to 5.

  3. Step 3

    Medication use

    If the patient uses pain relief medication for primary dysmenorrhea, it should remain unchanged in terms of type and strength. This medication can be used as standard pain relief during the trial.

  4. Step 4

    Evaluation of treatment response

    The primary goal is to assess if there is a reduction of at least 3 points in the peak pelvic pain score during the cramping window of Cycle 5 compared to the baseline.

    Additionally, there should be no increase in the number of standard pain relief medications taken during the cramping window of Cycle 5 compared to the baseline.

Who can join the trial?

10 criteria

  • Women aged 18-49 years who are able to give their consent to participate.
  • The patient must be informed about the clinical trial, agree to participate voluntarily, and sign the informed consent form.
  • The patient must have been diagnosed with primary dysmenorrhea, which means experiencing painful menstrual cramps.
  • If the patient takes pain relief medication for primary dysmenorrhea, they should continue using the same type and strength of medication as before the trial.
  • The patient must have a regular menstrual cycle lasting between 24 to 38 days.
  • The patient must agree to use one of the following contraception methods during the trial:
    • Bilateral tubal occlusion (a surgical procedure to block the fallopian tubes).
    • A partner who has had a vasectomy (a surgical procedure for male sterilization) and is the only sexual partner.
    • Sexual abstinence, meaning not having sexual intercourse, if it is the patient's usual lifestyle.
    • Using a male or female condom, with or without spermicide (a substance that kills sperm).
    • Using a cap, diaphragm, or sponge with spermicide.

Who cannot join the trial?

4 criteria

  • Women who are not experiencing primary dysmenorrhea cannot participate. Primary dysmenorrhea refers to painful menstrual cramps that occur in the absence of any other medical condition.
  • Men cannot participate in this study.
  • Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to be within the required age group.
  • Participants who are considered part of a vulnerable population may be excluded. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Vitex agnus-castus BNO 1095 is a herbal medication being studied for its potential to relieve symptoms of primary dysmenorrhea, which is a condition characterized by painful menstrual cramps. The trial aims to determine if this medication can improve the condition in women over the course of three menstrual cycles.

What is already known about the treatment

Vitex agnus-castus BNO 1095 – This medication is administered orally in the form of a 20 mg tablet. It is currently being studied in clinical trials to assess its effectiveness in treating primary dysmenorrhea, a condition characterized by painful menstrual cramps. The main therapeutic indication for this medication is to alleviate the symptoms associated with primary dysmenorrhea. At the molecular level, Vitex agnus-castus is believed to work by influencing hormone levels, particularly by modulating the balance of estrogen and progesterone, which can help reduce menstrual pain. It is classified as a herbal supplement, often used for its potential benefits in managing menstrual-related symptoms.

Investigated diseases

Primary Dysmenorrhea – This condition is characterized by painful menstrual cramps that occur just before or during menstruation. It is caused by the contraction of the uterus, which can lead to pain in the lower abdomen, back, and thighs. The pain can range from mild to severe and may be accompanied by other symptoms such as nausea, fatigue, and headaches. The discomfort typically begins a day or two before menstruation and can last for several days. It is a common condition among women, especially during adolescence and early adulthood. The severity of symptoms can vary from cycle to cycle.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503688-41-00Protocol codeAgnoMedEstimated enrolment300 patientsSponsorBionorica SE

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